Hyderabad: Authorization for the emergency use of Covaxin by Bharat Biotech and Covishield by the Serum Institute of India will be taken over by the subject matter expert committee on 1 January.
Both companies submitted additional data and information on the phase 3 studies. A review of the data has been carried out and the subject committee of experts of the Central Organization for the Control of Drug Standards will further analyze. Bharat Biotech has conducted phase 3 studies in more than 13,000 volunteers. Their target is 26,000 volunteers.
Meanwhile, on January 2, a dry race for Covid-19 vaccination will be held in all state capitals to test the links between planning and implementation and to identify challenges. It is proposed that the activity be carried out in at least 3 session sites in each capital.
The failure is a simulated drill to ensure that all requirements of participants, health workers, uploading data to the website and preparation for adverse events are in place.
There will be 25 beneficiaries of the tests who will be health workers. Their data must be uploaded to the Co-WIN (Covid Vaccine Intelligence Network) application. The space of the public health center, the waiting room, the logistics, the internet connectivity, the electricity and the safety must be calculated on the model’s sites.
Covid 19 safety protocols regarding masks and social distance must be observed. The designated center must have a cold chain for the storage and administration of vaccines.
An important emphasis of the drying period is the management of any adverse events after immunization. Therefore, there must be an emergency team to deal with the situation.
In a peer-reviewed journal, data published by Bharat Biotech states that long-term responses of antibodies and T cell memory were observed three months after vaccination in phase 1 studies. In phase 2, the vaccine was found to be safe. and that there was an improved cell-mediated immune response. After the vaccine doses, it is found that the immune response is good and will ensure the safety net.
The Serum Institute of India provided additional SEC data for examination. The emergency authorization by the UK Medicines and Health Products Regulatory Agency also played a role for the company to put pressure on the vaccine in India.
Pfizer has asked for more time to provide data, and for this reason, only these two vaccines will be taken for review.
Dr. Sanjay Reddy, a senior pharmacologist, said, “The committee will review data from the last 40 days. Experts will debate it and decide what is better. It is new research and there are new emerging strains that present a lot of challenges. Clinical contributions from both companies are very important for a EUA. The decision will be based on the clinical outcome of these vaccines. “
Pharmacologists who study different data and reports on compliance and adverse reactions in different countries say it is a “wait and see” policy.
A senior pharmacologist, on condition of anonymity. said. “We have a new strain that is also a concern. In light of these mutations, the most important thing is safety and efficacy. Both aspects must be considered before making the decision. Emergency use authorization is a new concept in India, and the mentality of people to accept a vaccine is a concern. We have to hope for the best. “